Pharma
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Dissolution Profiling Studies

Comparative, multimedia, and method development dissolution studies for solid oral dosage forms per USP and FDA guidance.

DissolutionCDPMultimediaBiowaiver
Overview

About This Service

AnalytiLab offers comprehensive dissolution testing and profiling services for solid oral dosage forms including tablets, capsules, and modified-release products. Our dissolution studies support bioequivalence submissions, SUPAC changes, formulation development, and QC release testing. We use USP Apparatus I, II, and IV with automated sampling and HPLC/UV quantification.

USP <711>ICH Q6AFDA Dissolution GuidanceEMA Dissolution Guidance

Key Information

ApparatusUSP I, II, IV
Turnaround Time7–14 working days
Regulatory AcceptanceUSFDA, EMA, ICH
pH Media1.2, 4.5, 6.8, 7.4

Accredited by

NABLISO 17025USFDA
Scope of Work

What's Included

Comparative dissolution profiling (CDP)
Multimedia dissolution (pH 1.2, 4.5, 6.8)
Dissolution method development
Dissolution method validation
f2 similarity factor calculation
Modified-release dissolution testing
Biowaiver support studies
SUPAC dissolution studies
Automated sampling with HPLC analysis
USP Apparatus I, II, and IV
Equipment

Instruments Used

Dissolution Apparatus USP I (Basket)

Capsules and floating dosage forms

Dissolution Apparatus USP II (Paddle)

Tablets and most solid dosage forms

Dissolution Apparatus USP IV (Flow-through)

Low-solubility drugs, implants

HPLC (UV/PDA)

Drug quantification in dissolution samples

Compliance

Regulatory Standards

USP <711>
ICH Q6A
FDA Dissolution Guidance
EMA Dissolution Guidance
Our Process

How We Work

01

Method Selection

Dissolution apparatus, medium, and conditions selected per FDA/USP guidance.

02

Method Optimization

Sink conditions verified; discriminatory method developed if needed.

03

Profiling Study

Dissolution profiles generated at multiple pH values; 12 units per condition.

04

f2 Analysis & Report

Similarity factor (f2) calculated; dissolution report with regulatory conclusions.

Get Started

Ready to Start Your Dissolution Profiling Studies?

Our scientific team is ready to assist. Submit your sample or request a quote today.